Clinical trial · Interventional
Safety Study of BLZ-100 in Adult Subjects With Sarcoma Undergoing Surgery
A Phase 1 Study of BLZ-100 Administered by Intravenous Injection in Subjects With Soft Tissue Sarcoma Undergoing Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study did not enroll any subjects
Summary
Brief summary (as posted)
Many types of cancer are primarily treated with surgery and patient survival is directly related to the extent to which the tumor is able to be removed. It is often difficult for surgeons to distinguish tumor tissue from normal tissue, and failure to surgically remove a cancer-affected lymph node or residual cancer at the surgical margin reduces a patient's chance of survival. Moreover, damage to adjacent normal tissue during surgery can result in significant morbidity. The investigators hypothesize that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of the tumor and small groups of cancer cells that have spread to other sites in real-time as they operate. This is a safety study to assess the safety of BLZ-100 in patients with soft tissue sarcoma undergoing surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma, Soft Tissue | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BLZ-100 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BLZ-100
- description
- All participants in the study will receive the investigational drug product BLZ-100. In part 1 of the study, two dose levels of BLZ-100 will be evaluated (3 mg and 12 mg) in 6 subjects, with a 2-3 post-dose imaging window. In part 2 of the study up to 15 additional subjects will be randomized to one of three imaging interval groups (up to 6 subjects/interval): Early Imaging (within 1 day post-BLZ-100 dose), Intermediate Imaging (2 - 3 days post- BLZ-100 dose), and Late Imaging (4 - 7 days post- BLZ-100 dose).
- interventionNames
- Drug: BLZ-100
Primary outcomes (1)
- measure
- Number of participants with adverse events
- timeFrame
- Seven days after study drug administration
- description
- Safety will be assessed by physical examination and measurement of vital signs and laboratory safety parameters.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male of female subject aged 18-75 years 2. Diagnosis of soft tissue sarcoma, with scheduled surgical removal for treatment for the disease and completion of chemotherapy or radiation within 4 weeks of BLZ-100 administration 3. Able to provide written informed consent 4. If of child-bearing potential, agree to continued use of two reliable methods of contraceptive from study entry (time of informed consent) through 30 days after BLZ-100 administration 5. Available for all study visits and able to comply with all study requirements Exclusion Criteria: 1. Clinically-suspected and/or pathologically-confirmed sarcoma of the bone (e.g. osteosarcoma, Ewing's sarcoma with bony involvement, chondrosarcoma, Kaposi's sarcoma, extraosseous primitive neuroectodermal tumor \[PNET\]) 2. Evidence of metastatic disease 3. Female who is lactating/breastfeeding 4. Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study 5. Karnofsky Performance Status of \<60% 6. Any of the following laboratory abnormalities at Screening: * Neutrophil count \<1.5 x 10\^9/L * Platelets \<75 x 10\^9/L * Hemoglobin \<10 g/dL (may be determined following transfusion) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3x upper limit of normal (ULN) * Total bilirubin \>1.5x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction) * Internal Normalized Ratio (INR) \>1.5 * Creatinine \>1.5x ULN * Calculated estimated glomerular filtration rate (eGFR) ≤60 mL/min 7. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) 8. QTc prolongation \>450 msec 9. History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine, and/or hospitalization 10. Uncontrolled asthma or asthma requiring oral corticosteroids 11. Known or suspected sensitivity to imaging agents that may be used in clinical assessment of this study 12. Known or suspected sensitivity to indocyanine green (ICG) 13. Unstable angina, myocardial infarction, known or suspected transient ischemic events, or stroke within 24 weeks of start of Screening 14. Uncontrolled hypertension 15. Initiation of new photosensitizing drugs within 30 days of Screening 16. Use of any ongoing medications, which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin®, and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix 17. Receipt of an investigational drug or device within 30 days of enrollment 18. Prior administration of BLZ-100 19. Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would adversely impact the subject or the interpretation of the study data
References
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